PMA P010020S019

Device: ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
Applicant: Boston Scientific Corp
PMA number: P010020
Supplement: S019
Product code: MIP
Decision date: 2010-12-16
Generic name: Implanted fecal incontinence device
Approval order statement: APPROVAL FOR A WARNING STATEMENT IN THE IFU PERTAINING TO THE APPROPRIATE CLEANING METHOD OF REUSABLE TOOLS USED IN THE ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER.

Current openFDA PMA Record

Device: ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
Applicant: Boston Scientific Corp
PMA number: P010020
Supplement: S019
Product code: MIP
Generic name: Implanted fecal incontinence device
Decision date: 2010-12-16
Decision code: APPR
Date received: 2010-11-18
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A WARNING STATEMENT IN THE IFU PERTAINING TO THE APPROPRIATE CLEANING METHOD OF REUSABLE TOOLS USED IN THE ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER.